Acuity is measured in each eye using the Amblyopia Treatment Study (ATS) visual acuity testing protocol at baseline and at 18wks resulting in a Snellen acuity score that can range from 20/16 to 20/800. The score is converted to logMAR (log of min angle of resolution) for statistical analysis, and a difference between the scores is calculated. A positive difference indicates acuity was better at 18wks than at baseline; a negative difference indicates acuity was worse at 18wks than at baseline.

Observational Study of Optical Correction for Strabismic Amblyopia in Children 3 to <7 Years Old

Official Title ICMJE

An Observational Study of Optical Correction for Strabismic Amblyopia in Children 3 to <7 Years Old

Brief Summary

This study will evaluate the effectiveness of refractive correction alone for the treatment of previously untreated strabismic or combined-mechanism amblyopia in children 3 to <7 years old with visual acuity of 20/40 to 20/400

Detailed Description

This study will evaluate the effectiveness of refractive correction alone for the treatment of previously untreated strabismic or combined-mechanism amblyopia in children 3 to <7 years old with visual acuity of 20/40 to 20/400.

A recently completed PEDIG study (ATS5) found that in 3 to < 7-year-old children with previously untreated anisometropic amblyopia, refractive correction alone improved visual acuity by 2 or more lines in 77% of the patients and amblyopia resolved in at least one third of the patients. These results supported previous observations from retrospective and pilot studies as well as Stewart et al's prospective report on 18 children with anisometropic amblyopia whose visual acuity improved after treatment with spectacle correction only.

Improvement in amblyopic eye visual acuity from treatment with optimum refractive correction in cases of anisometropic amblyopia is plausible because the refractive correction treats the underlying amblyogenic condition (i.e., uncorrected unequal refractive error) by providing retinal images of more similar clarity, size, and contrast. Elimination of the dissimilar retinal images, which may act as barriers to normal visual input, allows the amblyopic eye to receive appropriate visual stimulation. In contrast, visual acuity improvement with refractive correction alone in cases of amblyopia associated with strabismus is not expected to occur when the refractive correction does not completely eliminate the strabismus and restore fusion. In such cases, the underlying amblyogenic factor of a manifest ocular deviation remains; consequently, active cortical inhibition is presumably still present. Nonetheless, Stewart and colleagues recently reported finding gains in amblyopic eye visual acuity of children with strabismic and combined-mechanism amblyopia after a period of treatment with refractive correction alone. The PEDIG also observed this to occur in a subgroup of children with previously untreated strabismic and combined-mechanism amblyopia in a recent study. Amblyopic eye acuity improved by >= 2 lines from spectacle-corrected baseline acuity in 9 (75%; 95% CI = 43% - 95%) of the 12 patients with strabismic amblyopia and in 9 (69%, 95% CI = 39% - 91%) of the 13 patients with combined-mechanism amblyopia. Mean change from baseline to maximum improvement was 2.2 +- 1.8 and 2.6 +- 2.0 lines, respectively. These results are similar to those of Stewart and colleagues who reported visual acuity improvement averaging 3.0 lines in 16 children with strabismic amblyopia and 1.9 lines in 31 children with combined-mechanism amblyopia.

Although our results support the suggestion of Stewart et al. that strabismic amblyopia can improve with spectacle correction alone, they are not conclusive because both studies had small numbers of patients. Also, our classification of strabismus was based on alignment without refractive correction. Thus, a larger controlled study is needed to confirm or refute these findings in patients with strabismic and combined-mechanism amblyopia.

The ideal study design to answer the question of whether spectacles alone can significantly improve amblyopic eye visual acuity in strabismic children is a randomized trial with a control group who does not receive optical correction. However, most pediatric eye care providers would be reluctant to randomize esotropic children with hyperopic refractive error to a control group of no optical correction because of the likelihood of some children having accommodative esotropia, which would necessitate that hyperopic spectacles be prescribed. The number of esotropic amblyopes without an accommodative component is sufficiently few to make a randomized trial not feasible. Therefore, we have chosen to perform an observational study with a large number of children with pure strabismic and combined-mechanism amblyopia in order to evaluate the effect of refractive correction in this population of patients.

Study Type ICMJE

Observational

Study Design ICMJE

Observational Model: CohortTime Perspective: Prospective

Target Follow-Up Duration

Not Provided

Biospecimen

Not Provided

Sampling Method

Non-Probability Sample

Study Population

Community Sample

Condition ICMJE

Amblyopia

Intervention ICMJE

Not Provided

Study Group/Cohort (s)

Combined-Mechanism Amblyopia

Strabismus-Only Amblyopia

Publications *

Not Provided

* Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ICMJE

Completed

Enrollment ICMJE

156

Completion Date

December 2010

Primary Completion Date

May 2010 (final data collection date for primary outcome measure)

Eligibility Criteria ICMJE

Inclusion Criteria:

Age 3 to <7 years old

Able to perform visual acuity testing using the ATS single-surround HOTV protocol

Amblyopia associated with strabismus (comitant or incomitant) with or without anisometropia

*At least one of the following criteria must be met:

Heterotropia at distance and/or near fixation on examination (without spectacles)